Wednesday, 8 February 2006
Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005
The importance of the debate on this private member’s bill is demonstrated by the fact that senators are exercising a conscience vote. This is something which is not common in the parliament. The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, as the title suggests, seeks to remove the responsibility for approval of RU486 from the Minister for Health and Ageing and provide it to the Therapeutic Goods Administration. Of course, in the normal course of events, the Therapeutic Goods Administration is an institution tasked with the approval of medication and drugs which are for the treatment of illness and other sicknesses. The current process for approvals is detailed in the bill’s explanatory memorandum.
In 1996, amendments to the Therapeutic Goods Act were passed which placed medications such as RU486 in a special group of drugs known as restricted goods. According to the 1996 amendments, restricted goods cannot be evaluated, registered, listed or imported without the written approval of the Minister for Health and Ageing. In addition, any such written approval must be laid before each house of the parliament by the minister within five days of being given. RU486 is the only medicine that is subject to the restricted goods condition. One would therefore ask why RU486 attracts such attention. Put simply, RU486 acts to terminate a pregnancy. That is where the issue lies.
The consideration of the report by the Senate Community Affairs Legislation Committee—and I compliment the committee on the report and the work they have done over the last two months—reveals that the safety of RU486 remains an issue of concern. In medically induced terminations, RU486 can be used in conjunction with prostaglandin, a drug that stimulates contractions, resulting in the effective termination of pregnancies of less than seven weeks. Reported adverse side effects of RU486 include infection and septic shock. Haemorrhage, ruptured ectopic pregnancies, abdominal pain and nausea are also reported. Clinical trials conducted in the United States identified that surgical abortion was needed after medical abortion with RU486 and that there was a failure rate in six to eight per cent of cases.
One can see when looking at the Senate report that there are indeed concerns in relation to the possible harmful effects of this drug. Looking at the Senate report, I note that some submissions to the Senate inquiry referred to adverse events and deaths associated with the use of the drug and also concerns raised by the United States Food and Drug Administration. Although the United States Food and Drug Administration approved the use of RU486 in 2000, the decision is one of ongoing controversy. There remain grave concerns about the safety of this drug. In November 2004, the FDA reported that it had received reports of 676 adverse events, ranging in severity from minor symptoms such as nausea and dizziness to serious complications such as blood loss, ectopic pregnancy and rare bacterial infections which have been fatal in some cases.
Reference was made to at least 10 deaths having been associated with the use of RU486 in Europe and United States. Particular attention has been paid to the deaths of four young women in California over the past two years. These women all died of the same infection of the uterus within a week of taking RU486. Three of the families are now suing the manufacturer, Danco. The company says it has no answers as to how this occurred. The FDA is investigating recently reported serious adverse events associated with RU486 and has issued a public health advisory highlighting the risk of blood infection when using the American equivalent of RU486 in a manner that is not consistent with approved labelling. The FDA is reportedly convening a high-level meeting with experts from the Centers for Disease Control and Prevention early this year to examine these recent deaths.
There is also a move in the US congress to pass legislation suspending sales of RU486. The Italian government recently restricted imports of RU486 following the suspension of a trial of the drug in Turin. The trial was suspended after one in 20 women given the drug had partial abortions at home followed by excessive bleeding. I note also that a trial of the drug in Canada was suspended after the death of a young woman from toxic shock syndrome. In clinical trials in the United States, surgical abortion was needed after medical abortion using the American equivalent of RU486. As I said earlier, that failed in six to eight per cent of cases. The maternal mortality rate for RU486 abortion is estimated to be 10 times the rate for surgical abortion carried out at the same period of gestation.
The Senate Community Affairs Legislation Committee endorsed the conclusion of one submission that was made—that is, that the jury is still out on the safety of RU486. This is fair enough. But there is mounting evidence that the safety of this drug is an issue of crucial importance. It would seem therefore that there is little contest in relation to the potential harm of this drug to the health of women. I believe that, when you add the other aspects of this debate to it, this issue is one which should be decided only by the minister.
There has been a central question asked as to whether it should be the minister or the Therapeutic Goods Administration who approves. As I said earlier, why is there such a tension to this drug RU486? There are a number of reasons: one, it involves the termination of a pregnancy; two, it involves potentially serious effects which are harmful to women’s health, as I have mentioned; and, three, it is one which has been under the purview of the Minister for Health and Ageing. This is not just another drug. When you look at the social aspects of this and the concern that has been raised in the community about the debate on this particular drug, it is appropriate that a decision rest with the minister concerned. In fact, the Catholic Archbishop of Sydney emphasised the important distinction between therapeutic goods, which relate to the treatment or cure of disease, and a drug which acts to terminate a pregnancy.
People who have a concern with the minister having responsibility for this decision have expressed doubts about the lack of transparency and accountability. I believe that the foreshadowed amendments, which have been referred to by previous speakers, merit close attention. I understand that amendments are proposed in relation to the exercise of approval by the minister. I believe they go a long way to addressing the concerns expressed by many people who support the bill. The amendments require that the minister must seek certain advice before exercising his or her discretion. The decision to approve or not approve must be reported to the parliament. What is more, that decision must be subject, or is subject, as a disallowable instrument to the scrutiny of parliament.
I believe that those amendments really do answer the concerns people have expressed about the minister exercising this sort of control. I think discussions about who is the particular minister of the day or his or her particular beliefs are not appropriate in this debate. I believe that what we have in place has worked well, but I am prepared to support these amendments as being a means of addressing some of the concerns expressed and offering a degree of accountability to not only the people of Australia but also the parliament.
Having regard to those factors that I have outlined, and having considered this matter very carefully, I will not be supporting this bill. I might just add that I certainly agree with other senators who joined in this debate that this matter has been carefully considered by the Senate committee. I again congratulate them on their hard work—albeit that I do not agree with some of the members and their views—and I also congratulate those other senators who have contributed to this debate in a rational and mature fashion. This is, after all, a very important issue. As I said at the beginning, this is a conscience vote—and that demonstrates the importance of the debate. It is not something that we do every day in this parliament.